Real-World Validation of Health Innovation: a systematic review

b. Aim of review Real-World Data (RWD) and Real-World Evidence (RWE) are playing an increasing role in health care decisions. Electronic health records, the use of computers, mobile devices, wearables and other biosensors to gather and store huge amounts of health-related data has been rapidly accelerating. This data holds the potential to allow us to better design and conduct studies in the health care setting. Furthermore, Randomized Controlled Trials (RCT), the gold standard in the context of clinical guidelines, are time and resource-intensive, lack of generalizability and typically restricted to evaluating specific interventions one at a time. RCTs are being challenged by health care providers since they are looking for (RWE) to validate innovative interventions. This systematic review and meta-analysis will assess the literature to establishing a clearer definition and terminology of Real World Validation (RWV) including a better understanding of the associated methods, determining in how and in which contexts RWV has been used. c. Search and review methodology A systematic search of Cochrane Library, PubMed, MedLine (EBSCO), Web-of-Science (BIOSIS Citation Index, BIOSIS Previews, KCI-Korean journal database, Russian Science Citation Index, SciELO Citation Index), SCOPUS, and grey literature was performed independently by two reviewers using predefined criteria. d. Findings (Findings must be included and be relevant to the aims and/or objectives.) 1,153 records were identified, 254 titles and abstracted were scanned after the duplicates removed, 62 studies met the selection criteria and were considered for full-text review. e. Conclusions and implication The data collected suggested that Real-world Validation (RWV) is a cost-effective, relevant and adaptable mix-method user-inclusive methodology to assess the impact and benefits to patients, staff and the health economy, in a non-controlled environment by using RWD and RWE, of an innovation that has already undergone a pilot process. RWV generates insight, foresight, and explorative findings to bring a product to the healthcare market and to ensure its significance in clinical practice, grasping up with the principles of health economics and outcome research, thereby exhibiting the value of real‑world insights in healthcare decision